In the contemporary art, a remotely controlled On-Body Medical Device (OBMD) can be used for the continuous infusion of insulin to patients with diabetes. As each OBMD is no longer viable, however, a user must use a user interface (UI) that is paired to the OBMD to deploy and activate an ensuing OBMD.
Moreover, contemporary OBMDs are worn under clothing and attached to the body of the patient. Users typically change their OBMD at regular intervals as part of their routine. For example, a user may change their device every third morning when an OBMD reservoir is almost exhausted. Since most OBMDs are available in only one or two reservoirs sizes, typically the insulin reservoir is not completely exhausted at the start of a day or when the user may be leaving the privacy of their home. This situation creates a dilemma in which the user needs to either waste insulin by prematurely discarding the patch pump or compromise their privacy and discretion by having to change their patch pump in public.
Additionally, electronic clocks utilized in remotely controlled OBMDs with wireless communication, such as real time clocks (RTCs), can vary due to inherent limitations on accuracy and ambient conditions such as temperature or the like. The time delay in the current state of the art for RTCs can be approximately 2 minutes per year, which equates to approximately one second over three days.
Finally, the removal of non-viable contemporary OBMDs from the skin of a user may cause tissue damage. The adhesive can remove portions of the outer surface of the skin that are in contact with the adhesive, making the resulting skin surface more susceptible to infection, and rendering the site less viable as an infusion site, albeit temporarily.
While there are products on the market such that are effective in removing adhesive pads from skin, they are currently packaged as stand-alone products—principally wipes or sprays. This presents several difficulties for the user. For example, it is another device that the user has to keep track of, and it can be difficult to apply if an OBMD is not in the line of sight. Also, many adhesive solvents, such as siloxane are flammable. The contemporary methods for using siloxane expose the solvent to air and the ambient environment, thereby increasing the risk of ignition.
Accordingly, there is a need for a fluid delivery system that provides user discretion, reduces Insulin waste, reduces many use steps in deploying each ensuing OBMD, and allows compliance with prescribed therapy.
Moreover, there is a need for a fluid delivery system to recognize failure and end of service conditions and through active communication with other OBMDs in the system provide uninterrupted therapy. Related to this requirement is a need for a communication method that minimizes power consumption and thereby reduces the power requirements and overall size of the OBMD and UI.
There is also a need for a system for reducing or eliminating the peel force and tissue damage associated with removing the adhesive pad of an OBMD. There is, in addition, a need to have a means of adhesive removal integrated with the infusion device.